MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-11 for PIPELLE DE CORNIER MARK II 1111200 manufactured by Prodimed.
[27336966]
By observing the returned broken pipelle tip, it appears that the pipelle has been broken at the roughening part. This medical device is currently roughened on the last 3 cm on its' extremity. The first hypothesis is that the roughening process could have weakened the medical device. So we checked the process of roughening; the parameters of roughening machine are adjusted to avoid to roughen too much the tip of the medical device that could lead to a too small thickness of the extremity of the device. The parameters applied on this batch were conformed to the specifications. The second hypothesis is an error of an operator. However, we checked the dhr and found no deviation in the process. Furthermore, it's been at least 4 years since we've had this type of incident with (b)(4) units sold since 2012. The most probable root cause is an error during the use of the device: the tube may be weakened by a sharp object before use.
Patient Sequence No: 1, Text Type: N, H10
[27336967]
Patient presented for endometrial biopsy for research clinical trial therapeutics txc (b)(6). When the pipelle was withdrawn, 3. 5cm of the outer sheath was missing and was retained in the endometrial cavity. The patient required a hysteroscopy d&c under general anesthesia to retrieve the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612445-2015-00001 |
| MDR Report Key | 5117896 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-08-04 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2015-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATUCCA MLAURE |
| Manufacturer Street | 4 RUE DE L'EUROPE, ZI |
| Manufacturer City | NEUILLY-EN-THELLE |
| Manufacturer Country | FR |
| Manufacturer Phone | 344266346 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIPELLE DE CORNIER MARK II |
| Generic Name | NA |
| Product Code | HHK |
| Date Received | 2015-09-11 |
| Returned To Mfg | 2015-08-24 |
| Model Number | 1111200 |
| Catalog Number | 1111200 |
| Lot Number | 6103/C909 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODIMED |
| Manufacturer Address | 4 RUE DE L'EUROPE, ZI NEUILLY-EN-THELLE 60530 FR 60530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-11 |